- Ensure timely and efficient creation/review of QCRM documents (material specifications, standard operating procedures, test methods, technical protocols and reports, etc.) Contribute scientific knowledge, analytical skills, and interpretation of the information to be captured on the document
- Ensure a consistent style of presentation of QCRM documents to maintain quality and ease of review Execute activities, associated with optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materials
- Coordinate and conduct tasks for laboratory equipment calibration, qualification, preventative maintenance and re-qualification program Act as subject matter expert (SME) for method validation, laboratory equipment management and supplier certification testing, and provide input in cross-functional teams, including during Consent Decree remediation activities.
- Provide training and ensure adequate proficiency of QCRM staff with respect to analytical method principle and critical parameters; ensure understanding and interpretation of test results Support readiness for regulatory inspections and compliance audits.
- Assess routine compendial updates and ensure timely revision of test methods Review data generated by contract laboratories (internal and external labs) Support development of junior analysts through mentoring
- Execute and ensure timely closure of compliance events, including deviations, CAPA, change controls Revise standard operating procedures as needed Practice safe work habits and adhere to Genzyme s safety procedures and guidelines
- Maintain proficiency training per assigned curricula
Skills: Basic Qualifications: Bachelor s degree in a related discipline Minimum of 5 years of experience in cGMP laboratory environment Previous experience with management of lab equipment Previous experience with lab control operations and quality systems
Education: Bachelor s degree in a related discipline Previous experience with lab control operations and quality systems .
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3348 | Fax: 973.998.2599
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